To plan and Manage Medical Writing for Regulatory and Pharmacovigilance Verticals in compliance to applicable regulatory and Regulatory Guidelines.
Duties and responsibilities
- Providing high-quality medical and scientific writing from planning and coordination of literature search through delivery of final drafts to internal and external clients.
- Prepare and review drug safety related documents including but not limited to PADERs, PSURs, PBRERs, ACO, Signals reports and risk management plans.
- Review literature search and related documents required for aggregate reports.
- Ensure a comprehensive and consistent aggregate analysis performed to establish the risk benefit profile of the product that meets all regulatory authority’s requirement.
- Generate line listing as required for the aggregate reports.
- Preparation of annual calendar for all required aggregate reports. Record and track receipts, submissions and distributions of documents with respective local affiliates.
- Writing and updating of CTD Modules, Medical Data Packages, SmPCs, PIs, PILs, and other country specific documents.
- Author responses to regulatory agency/ Pharmacovigilance Risk Assessment Committee (PRAC) inquiries, as required.
- Carry out detailed searches in regulatory agency websites like US FDA, EMA, PMDA, TGA, UKMHRA etc for safety alerts.
- Work in coordination with all the cross-functional teams internal and external for the development of safety and aggregate report related documents.
- Demonstrate subject matter and therapeutic area expertise.
- Effectively manage medical writing projects to deliver quality products in agreed specifications and timelines.
- Maintain awareness of current regulatory guidance, medical information techniques and technology relating to clinical / regulatory documentation
- Mentor Associates on job skills, oversees or develops training plans or materials for safety associates, conducts training sessions, or otherwise trains new hires and enhances the skills of existing personnel.
Education & Experience
- Master’s degree in a Pharmacology/Pharmacy/Medicine, Advanced degree preferred
- Previous experience of atleast 3 years in Aggregate report and Risk management plan required.
- Experience working in the pharmaceutical/CRO industry preferred
- Additional qualifications in medical writing (AMWA; EMWA; RAC) advantageous
Knowledge, Skills and Abilities
- Excellent data interpretation and medical writing skills, including grammatical, editorial, and proofreading skills
- Strong project management skills
- Excellent interpersonal skills including problem solving
- Strong negotiation skills
- Excellent oral and written communication skills with strong presentation skills
- Significant knowledge of global, regional, national and other document development guidelines
- In-depth knowledge in a specialty area such as preclinical, therapeutic, regulatory submissions, communications, etc.
- Great judgment and decision-making skills
- Excellent computer skills and skilled with client templates; Good knowledge of document management systems and other relevant applications (e.g. Excel, Outlook)
- Ability and desire to work in a team-oriented environment.
- Excellent written and verbal communication skills
- Highly proficient with Microsoft Word, PowerPoint and Excel.
- Demonstrates ability to evaluate information and data with a defined, studied process and report results in a thoughtful, organized manner
- Possesses a collaborative, results-driven style.
- Ability to work under pressure and provide quality outputs within tight timelines
As may be required from time to time – the incumbent may be required to working slots catering to different time zones